Phase 2
N=12
Use of Donepezil for Treatment of Cocaine Dependence
Cocaine Abuse and Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00467389 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Cocaine Safety in Subjects Receiving Donepezil — 0; 2 Participants with an Adverse Event
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Donepezil, 5 mg daily (Drug); Oral Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Safety in Subjects Receiving Donepezil |
0; 2 | — |
| SECONDARY Cocaine Subjective Effects |
44.1; 89.9 | — |
| SECONDARY Cocaine Pharmacokinetics |
34,503; 40,812 | — |
Summary
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
Eligibility Criteria
Inclusion Criteria
- Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.
Exclusion Criteria
- Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
- Has a current psychiatric disorder other than drug abuse or dependence or dementia.
- Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
- Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.
- Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.
- Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.
- Has had head trauma that resulted in neurological sequelae.
- Has an unstable medical condition, which, in the judgement of investigators, would make participation hazardous.
Data sourced from ClinicalTrials.gov (NCT00467389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.